CORNEREGEL EDO

CORNEGEL EDO eye gel

Important notes (mandatory information)

Corneregel EDO Eye Gel Active ingredient: Dexpanthenol. Areas of application: for the treatment of non-inflammatory corneal diseases of the eye (keratopathies), e.g. corneal dystrophies (nutritional disorders), corneal degenerations (regressions), recurrent corneal erosions (exfoliations) and corneal lesions (injuries) in contact lens wearers; as additional medication to support the healing process in the event of corneal and conjunctival damage, corrosion and burns; as additional medication to a specific therapy for infectious corneal processes of bacterial, viral or mycotic (caused by fungi) origin.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Corneregel EDO Eye Gel
Active ingredient: 1 g of eye gel contains 50 mg of dexpanthenol.

Please read the entire package leaflet carefully, as it contains important information for you. This medicine is available without a prescription. However, in order to achieve the best possible treatment results, you must use Corneregel EDO as prescribed.

• Please keep the package leaflet. You may want to read it again later.
• Ask your doctor or pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, be sure to see a doctor.
• If any of the side effects listed here affect you significantly or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS CORNEREGEL EDO AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING CORNEREGEL EDO?
3. HOW TO USE CORNEREGEL EDO?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CORNEREGEL EDO?
6. FURTHER INFORMATION

1. WHAT IS CORNEREGEL EDO AND WHAT IS IT USED FOR?

Corneregel EDO is a wound healing agent.

Corneregel EDO is used:

• for the treatment of non-inflammatory corneal diseases of the eye (keratopathies), e.g. corneal dystrophies (nutritional disorders), corneal degenerations (regressions), recurrent corneal erosions (exfoliations) and corneal lesions (injuries) in contact lens wearers,
• as additional medication to support the healing process in the event of corneal and conjunctival damage, corrosion and burns,
• as additional medication to a specific therapy for infectious corneal processes of bacterial, viral or mycotic (caused by fungi) origin.

Corneregel EDO is not suitable for healing infectious corneal processes of bacterial, viral or mycotic origin, but only as additional medication to a specific therapy for these corneal diseases.

2. WHAT SHOULD YOU CONSIDER BEFORE USING CORNEREGEL EDO?

When should you not use Corneregel EDO?
You should not use Corneregel EDO if you are known to be hypersensitive to any of the ingredients. Special care should be taken when using Corneregel EDO as a contact lens wearer: Contact lenses should be removed before use and not reinserted until 15 minutes after instillation of Corneregel EDO.

When using Corneregel EDO with other medicines

No specific interactions with other agents are known, but when using other medicines on the eye, there should be a period of at least 15 minutes between the application of the different medications. Corneregel EDO should always be used last so that the residence time and thus the effect is not reduced. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are not prescription medicines.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using any medicine. Since it is not known how much dexpanthenol is absorbed into the bloodstream after local application to the eye, the benefits of using Corneregel EDO during pregnancy and breast-feeding should be carefully weighed against any possible risks. You should tell or show your ophthalmologist as well as your internist or family doctor all the medicines you are taking or using locally on your eye.

Driving and operating machinery

Since this medicine, even when used as directed, can briefly affect vision and thus reaction time due to the formation of streaks, you should not participate in road traffic, work without a secure hold or operate machinery during this time.

3. HOW TO USE CORNEREGEL EDO?

Always use Corneregel EDO exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure.

Type of application

For use on the eye.

Dosage

The dosage may vary depending on the severity and nature of the condition. In general, it is sufficient to instill 1 drop into the conjunctival sac 4 times a day; the last time approximately 15 minutes before going to bed.

Duration of use

The duration of use is not limited. The application should be continued until the symptoms subjectively improve.

If you have used more Corneregel EDO than you should

No overdose reactions are known.

If you forget to use Corneregel EDO

Do not use a double dose. Continue the therapy at the next scheduled time with the same dosage and at the same time interval/rhythm as described or as prescribed by your doctor. If necessary, you can also use Corneregel EDO between two scheduled times or make up for a missed application.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Eye disorders

Eye irritation, e.g. redness, pain, foreign body sensation, increased tearing, itching, conjunctival swelling.

Immune system

Very rare (less than 1 in 10,000 patients): Hypersensitivity reactions, e.g. itching, rash.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE CORNEREGEL EDO?

Keep out of reach of children! Do not use the medicine after the expiry date. You will find the expiry date on the folding box and the single-
Dose ophthalmic.

Storage condition

Do not store above 25 °C! Protect from light!

Note on shelf life after opening

Corneregel EDO does not contain a preservative. Opened single-dose ophthalmic vials should therefore not be stored. The remaining amount of eye drops remaining in the ophthalmic vial after use must be discarded.

6. FURTHER INFORMATION

What does Corneregel EDO contain?
Active ingredient: 1 g of eye gel contains 50 mg of dexpanthenol. Other ingredients: Carbomer (viscosity 40,000 – 60,000 m Pa s); sodium hydroxide; water for injections.

What does Corneregel EDO look like and what does the pack contain?
Clear, colourless eye gel. Packs of 10, 30, 60 and 120 single-dose ophthalmic vials (bundle pack of 2 x 60 single-dose ophthalmic vials) with 0.6 ml of eye drops each.

Pharmaceutical entrepreneur and manufacturer

Dr. Gerhard Mann,
Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165-173,
13581 Berlin
Telephone: 030-33093-5050
Fax: 030-33093-350
E-mail: ophthalmika@bausch.com

Co-distributed by

Bausch & Lomb GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Telephone: 030-33093-5050
Fax: 030-33093-350
E-mail: ophthalmika@bausch.com

This leaflet was last revised in January 2011.

Source: Information from the package leaflet
Status: 03/2016
Active ingredient: Dexpanthenol. Areas of application: for the treatment of non-inflammatory corneal diseases of the eye (keratopathies), e.g. corneal dystrophies (nutritional disorders), corneal degenerations (regressions), recurrent corneal erosions (exfoliations) and corneal lesions (injuries) in contact lens wearers; as additional medication to support the healing process in the event of corneal and conjunctival damage, corrosion and burns; as additional medication to a specific therapy for infectious corneal processes of bacterial, viral or mycotic (caused by fungi) origin.